Q-If, for any reason, an English-speaking research participant is not able to read a consent form (i.e., illiteracy, vision-impairment), how should this individual’s consent to participate be documented?
A-In cases where the research participant is not able to read, the informed consent dialogue becomes extremely important. An impartial witness should be present during the entire informed consent conversation. The text of the informed consent document and any other written information should be read aloud by the person obtaining consent. The participant should be encouraged to ask questions and allowed to have questions answered, as is usual during a normal consent process. If the research subject wishes to enroll in the study the subject may consent orally and if able, may sign and date the consent form. After the subject has consented, the witness signs and dates the consent form to attest that the subject received the information, the risks/benefits/alternatives were discussed, and informed consent was freely given. A complete and explicit description of why the participant was not able to sign the document should be included in the chart to provide a clear record of the event and the surrounding circumstances. For additional information, see Guidance for Industry – Documenting Informed Consent, Section 4.8.9 @ http://www.fda.gov/cder/guidance/959fnl.pdf
